FDA Names Flatiron Health Executive Amy Abernethy Deputy Commissioner

Healthcare
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Amy Abernethy, chief medical officer of Flatiron Health, sits with Robert Califf, at a company event early this year.

Flatiron Health

The Food and Drug Administration has named Amy Abernethy, currently the chief medical officer at Flatiron Health, a unit of the drug giant Roche, to one of its highest positions. She will start in a few months.

“She’s a highly regarded thought leader who has held numerous positions of leadership in her fields of interest and distinguished herself for her intellect, her passion for patient care and science, and her collegiality,” Scott Gottlieb, the FDA Commissioner, wrote in a memo to FDA staff announcing Abernethy’s appointment. Robert Califf, the previous FDA commissioner and a mentor of Abernethy’s, echoed Gottlieb’s praise. “In my wildest dreams, I wouldn’t have imagined Scott could come up with somebody this highly qualified,” Califf said. “So I think it’s really good for the country. I’m really excited about it.”

Abernethy says that the role was too meaningful to pass up. “I had always thought I would go into government service, and I have always believed that one of the ways you make change is through policy and regulation,” she says. She hopes to work on speeding up the collection of data that can be used in clinical trials—“Historically, patient-defined concerns were always secondary, and the question is: How do you make the needs of the patient the obvious thing that we’re working on?” she says—and on making sure patients get the right treatment at the right time, including by using more genetic tests, an idea known as precision medicine. “The more we have precision medicine the more it means we stop doing things that don’t work,” she says. But she also acknowledges that the role is broad, and that she may end up working outside her specific plans. “This is not my chance to solve the set of problems I think are important,” she says. “It’s a chance to spend 100% of my time solving problems that are important for human health.”

Abernethy’s research has often focused on answering questions industry had little financial incentive to address. A 2010 study, financed by the National Institutes of Health, showed that in 239 patients with shortness of breath, breathing from an oxygen tank was not superior to simply breathing the air in their rooms. Much of her work has focused on imagining how getting data from patients in real-time could allow the healthcare system to “learn” more quickly, leading to better care. That led her to work, initially, with the American Society of Clinical Oncology to create a data network, and later to her role at Flatiron Health. Flatiron has a business model of using data from patient health records to create research that can be useful to pharmaceutical companies. But one of Abernethy’s major recent papers showed something that wasn’t that flattering to companies like Roche, which also owns a firm that does genetic cancer testing, Foundation Medicine. Patients that got tests like Foundation’s lived no longer than those who didn’t in Abernethy’s study, largely because doctors rarely prescribed a different treatment based on the test result. At Flatiron, Abernethy also continued to push for other ideas: a 2017 editorial in Nature Reviews Clinical Oncology, argued that there was more need to ask patients, in a structured way, how they are feeling.

For Flatiron, which is just starting to see the FDA consider the use of its data and to gain traction with pharmaceutical companies, her departure will represent a challenge. The company was featured in a November cover profile in Forbes.

“It’s bittersweet,” says Nat Turner, Flatiron’s cofounder and chief executive. “She had a lot to do with this. We’re really excited though. The FDA—I think if she had gone anywhere else it would have been tougher, but the FDA is so central to what we do at Flatiron because real-world evidence is so key to what we do, there are just so many opportunities to advance the ball.”

Turner clarified that he’s certain that Abernethy’s work will have nothing to do with Flatiron directly. But her tenure is likely to be shaped in part by how the FDA chooses to deal with the potential conflicts of interest raised by her most recent role.

An FDA official at Abernethy’s level would rarely make decisions that directly impact any single company. But she will be involved in shaping larger regulations that will impact how data collected from clinical practice, called “real-world evidence” by researchers, can be used. In his memo to staff, Gottlieb, the FDA commissioner, said that Abernethy’s ethics review is still pending. It will likely help that she is unlikely to own large amounts of stock in either Flatiron or Roche, because Roche paid for Flatiron in cash.

Abernethy says she plans to be proactive in dealing with those issues. She compared her expertise in the use of data to being an expert in the biology surrounding a particular drug. A conflict, she says, does not erase the expertise. “I happen to be a methods expert in data, that is what my expertise is in, full stop. As the issue is how to use data, you would argue that Flatiron is a data company and FDA is a data agency.” Still, she says, the exact rules regarding what she will and won’t do at the FDA have not been set. She says: “I will follow the rules.”